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Contents
Dementia Drugs
Acetaminophen Reorganization of Dr. Reddy’s Labs Generic Biotech FDA Guidelines to Industry St. John’s Wort for Parkinson’s Disease Thalidomide The BIO International Convention Top Alzheimer’s Investigators Dementia Drugs Cholinesterase inhibitors (Aricept, Exelon and Reminyl) are often prescribed for people with Alzheimer's disease and related dementias because they increase the level of a chemical in the brain that seems to help memory. Although such drugs are known to provoke slower heart rates and fainting episodes, the magnitude of these risks has not been clear until now. In a large study using province-wide data, published in the journal Archives of Internal Medicine, scientists discovered that people who used cholinesterase inhibitors were hospitalized for fainting almost twice as often as people with dementia who did not receive these drugs. Experiencing a slowed heart-rate was 69 per cent more common amongst cholinesterase inhibitor users. In addition, people taking the dementia drugs had a 49 per cent increased chance of having permanent pacemakers implanted and an 18 per cent increased risk of hip fractures. Acetaminophen U.S. drug regulators may take steps to help prevent liver damage from a popular painkiller. People can buy acetaminophen with or without a prescription. Tylenol is the best known brand, but generics also are sold. Large doses can cause liver damage. But a report by the U.S. Food and Drug administration says people may not be aware of the risk. The report was released this week. It recommends a stronger warning label and a lower maximum dose. The current adult maximum is 4,000 milligrams a day. The report advises reducing it to 3,250. Outside experts who advise the agency will discuss the report at a meeting in June. Reorganization of Dr. Reddy’s Labs Dr. Reddy’s announced that effective July 1, 2009 the Drug Discovery operations at Hyderabad will be absorbed into Aurigene, a wholly owned independent subsidiary of the company. Aurigene is a partnership based Drug Discovery biotech headquartered in Bangalore. The Discovery Research resources - employees, facility and infrastructure will transition into being resources of Aurigene, which will now operate out of two sites - Bangalore and Hyderabad. In addition, Dr. Reddy’s will be creating a new group to focus on Proprietary Products development, which will be responsible for building the proprietary, branded R&D portfolio in collaboration with various partners and service providers. This organization will work with Aurigene and other Discovery Biotechs to ensure effective management of the ongoing and future drug discovery programs. All the existing Intellectual Property will be owned and managed by this new unit. This group will also have responsibility for the development portfolio and the company’s differentiated formulations efforts. As part of the reorganization, the company will close the Atlanta Research facility in the US. Generic Biotech Bipartisan legislation proposing the use of generic biotech drugs instead of biotech drugs for cost-effectiveness is picking up steam within congress. A proposal for generic brand biotech drugs (S.726) was authored by Sen. Charles Schumer, D-N.Y., and Susan Collins, R-Maine, in late March. The bill is similar to H.R. 1427, introduced by Rep. Henry A.Waxman, D-Calif. While biotech companies are asking for products to be on the market for 14 years before facing generic competition, the bill only allots just five years of market exclusivity and up to three more years for modifications. According to reports, Sen. Ted Kennedy, D-Mass, who heads the committee that oversees the FDA, will not endorse a five year approach. Instead, Kennedy seeks a plan where biotech drugs could have market exclusivity for 12 years. With the shortened time of market exclusivity planned for biotech drugs, organizations are speaking out on how it could affect the economy. The Pharmaceutical Research and Manufacturers of America (PhRMA) believes the shortening of market exclusivity might discourage biotech companies from investing in drug development, jeopardizing new medicines to come to market FDA Guidelines to Industry The Food and Drug Administration issued proposed advertising guidelines for drug and medical device makers with suggestions about how to properly present risk information in promotional material aimed at consumers and health-care professionals. The draft guidelines contain several suggestions to industry on how to avoid running afoul of agency rules. The FDA said the mission or minimization of risk information is the most frequent violation of the regulations cited in dozens of enforcement or warning letters sent to sponsors each year. The agency said, "the public health is best served when risk and effectiveness information about drug and device products is clearly and accurately communicated." The FDA said it looks at the "net impression" of a consumer advertisement or material given to doctors to determine if a piece conveys accurate information about a particular product. The FDA said promotional material can be misleading even if specific individual claims or presentations aren't misleading. As an example, the FDA said an advertisement for a cholesterol-lowering drug that uses audio to lay out the drug's side effects could be considered misleading if it contains upbeat music and "discordant" images of patients benefiting from the medicine while the risk information is detailed. The FDA explains, “Memory research consistently shows that, in an experimental setting, when people process an entire list or text, they are better able to recall items at the beginning and the end than items in the middle.” Another tidbit on the human mind, “The amount of information presented is one component that, together with choice of words, color, graphics, voiceover, and other aspects of the piece, can affect cognitive load, the mental effort required to understand the various components of information in the piece.” The 24-page guidance document goes into detail about how fonts, the type of contrast and white space used in print materials can be used to best present risk information. The guidelines suggest a product that requires monthly blood tests to check for liver damage should state that in clear language rather than using statements that state there's a need for "certain monitoring." The agency will be accepting comments on the draft guidance document for 90 days before it issues final guidelines. Meanwhile, President Barak Hussain Obama's pick to oversee food and drug safety said during her Senate confirmation hearing that she would revamp the FDA to better protect the nation's food supply. Margaret Hamburg, a bioterrorism expert who once served as New York City health commissioner, also said she wants to restore public confidence in the FDA. President Obama wants Congress to give the Food and Drug Administration an additional $300 million in its budget, which the agency called the largest funding boost in its history. The budget also factors in about $75 million in user fees from food companies to inspect food plants and $36 million from generic drug makers to review generic drug applications. The FDA doesn't yet have the authority to collect these fees, and the budget notes these numbers are "contingent" on legislation passing in Congress. Although new user fees and fee increases have tended to provoke opposition among brand name drug makers, generic drug manufacturers are prepared to support such fees this time, in order to speed their application process at the FDA. Many generic applications get stalled at the agency because they require a referral from the generic division to the drug evaluation offices or the biologic drug centers for more detailed consultation reviews. The drug evaluation and biologic centers process brand name applications first because brand-name drug makers pay fees to get their medicines reviewed. St. John’s Wort for Parkinson’s Disease Investigations have revealed evidence of lipid peroxidation as well as oxidative damage to the DNA of brain proteins in patients suffering from the disease. The increase of oxidative stress is attributed, among other factors, to a less active mitochondrial complex I. Certain environmental contaminants such as pesticides can cause Parkinson's. The hypothesis is that the increase in the production of Reactive oxygen species (ROS) caused by the altered function of the mitochondrial complex I could be the cause of the degeneration of dopaminergic neurons through the apoptotic process. Ingesting high quantities of antioxidants may reduce the risk of suffering from Parkinson's disease or delay its progression. Approximately one third of the best selling drugs in the world are, or derive from, natural substances. St John's wort (Hypericum perforatum) presents proven antioxidant effects, which make it beneficial for all those pathologies that cause an increase of free radicals. The evaluation of neuron degeneration caused in the substantia nigra shows a reduction of dopaminergic neuron death with St John's wort. The neuron protecting effects are greater with the standard Hypericum Perforatum extract with the 0.3% concentration of Hypericin. http://www.sciencedaily.com/releases/2009/05/090511181252.htm Thalidomide Mothers had taken thalidomide to relieve their morning sickness in the late 1950s and early 1960s. About 10,000 babies whose mothers took the drug were born with disabilities. The most common defect was to the limbs of babies. They were born with stunted arms or legs or, in some cases, no limbs at all. It took some time for evidence of birth defects to be linked to thalidomide. The drug was taken by women early in their pregnancy to combat morning sickness, typically at around five to nine weeks, although morning sickness in some women can last a lot longer. This specific timeframe is crucial as that is when the limbs of babies are still forming. The blood vessels involved in this process, at this stage of pregnancy, are still at an immature stage when they rapidly change and expand to accommodate the outgrowing limb. A University of Aberdeen-led team said a component of the drug prevents the growth of new blood vessels in the developing embryo. The paper has been published in Proceedings of the National Academy of Sciences. In the 1960s, it was discovered the drug had an effect on some of the painful symptoms of leprosy. And in the 1980s, scientists once again became interested in the drug's complex properties when researchers began to explore its use in the treatment of a number of diseases, such as cancer. The BIO International Convention The BIO International Convention is the world’s largest annual event for the biotechnology industry. The 2009 Convention ran Monday, May 18 through Thursday, May 21 at the Georgia World Congress Center in Atlanta, Ga. Next year’s event will be held May 3-6, 2010 at McCormick Place in Chicago, Ill. Sir Elton John, a keynote speaker, spoke about the urgent need to develop improved treatments, delivery methods and a cure for HIV/AIDS. Health care policy keynote featured Sen. Thomas Daschle (D-S.D.); William Frist M.D., former Majority Leader of the U.S. Senate; Gov. Howard Dean (D-Vt.); Mr. Karl Rove, former Senior Advisor and Deputy Chief of Staff to former President George W. Bush; and, Susan Dentzer, Editor-in-Chief of Health Affairs. The panel discussed current biotechnology-related bills under consideration in the U.S. House and Senate, policy options to increase access to quality health care, the need for capital and investment in the biotech industry, and how to control costs within the health care system. The full Convention program featured more than 170 sessions in 22 breakout session tracks, including new tracks on drug delivery, global biotechnology issues, translational medicine and vaccines, among others. In addition, this year’s BIO Exhibition covered an estimated 176,000 net sq. ft. and hosted 1,827 exhibitors. The BIO International Convention helps support BIO programs and initiatives. BIO works throughout the year to create a policy environment that enables the industry to continue to fulfill its vision of bettering the world through biotechnology innovation. http://convention.bio.org. The BIO will host a side event at the upcoming UNFCCC Climate Change Talks in Bonn, on Monday, June 1st from 7:30 p.m. to 9:00 p.m. Biotechnology offers a broad range of tools to address climate change. This briefing will focus on clean, renewable alternatives to petroleum-based fuels and products, reduction of greenhouse gas emissions from industrial processes, and the use of sustainable agricultural practices. Top Alzheimer’s Investigators A landmark study in which both traditional and highly-innovative scientometric approaches are employed to measure scientific productivity and impact of the top 100 Alzheimer's disease (AD) investigators appeared in the March 2009 issue of the Journal of Alzheimer's Disease. The field of AD research, which marked its centennial in 2006, has progressed at a rapid rate since the late 1970s. Considering the broader field of neuroscience, of the estimated 135,000 actively publishing scientists worldwide, roughly 18% (or 25,000), have published one or more papers on AD. In spite of the increasing share of neuroscience activity focusing on AD, there has not been a comprehensive, objective analysis of AD research through scientometrics. Source: The primary sources cited above, BBC News, New York Times (NYT), Washington Post (WP), Mercury News, Bayarea.com, Chicago Tribune, CNN, USA Today, Intellihealthnews, Deccan Chronicle (DC), the Hindu, Hindustan Times, Times of India, AP, Reuters, AFP, Biospace etc. Notice: The content of the articles is intended to provide general information. Specialist advice should be sought about your specific circumstances. |
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